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Thread: Comment on the SCINetUSA phase I/II and III trials

  1. #21
    Quote Originally Posted by Wise Young View Post
    It is hard to tell. If everything is in order, an approval within a year after the clinical trial could happen.

    Wise.
    Hi Wise, While the whole SCInet approach sounds good and rational, I wander if Scinet is also planning or will plan in near future to bring any other possible treatment for clinical trial? For example, As you yourself have mentioned in some older articles of yours, finding an approach to over come the scar tissue(CSPG) must also be high on the agenda. While Nogo and Cethrin are in clinical trial, 2 other approaches, namely Chondroitinase AB from Accorda and Decorin of Dr Davies must also be brought to clinical trial as soon as possible along with the other combination therapies being tried.

    So may be Scinet can actively look at collaborating with the concerned parties to bring these 2 others to clinical trial as soon as possible. If these are shown to work, then a few years down the line, these can be tried in a combination therapy with your UCBMC or any other that may be available.

    Another question, Since many from outside USA are also supporting the Scinet and expecting a lot out of it, So how long it may take to bring it outside USA to Asia and Europe assuming everything goes right and FDA approves within an year? From your post, i get the feeling that only UCBMC from one company can be used as it will be their IP. Now will that company also make their UCBMC available to other cord blood banks present in other countries(like India) through tie ups?

    Rabindra

  2. #22

    Dr.wise

    Quote Originally Posted by Wise Young View Post
    Skeaman, the requirements are two phase III trials that the FDA agrees will show efficacy of the therapy. We are therefore doing two trials. One in China and one in the U.S. We will be registering both trials with the U.S. FDA.

    One has to discuss the trials with the FDA to make sure that the outcome measures fit with what that FDA believes are reasonable. It is possible that the FDA may require a functional outcome. It is also possible that they would want us to compare the treatment group against what they consider to be appropriate controls.

    How long it will take for approval depends on the results. If the results are what the FDA agrees would show efficacy and the treated groups meet the criteria for efficacy, the FDA may approve pretty quickly but an approval requires several other things besides a clinical trial to show efficacy.

    The FDA will want to ensure that the product (i.e. cells is what we say that it is, inspect the manufacturing process, and determine that it meets GMP or good manufacturing practices). This should be reasonably quick because the umbilical cord blood cells are being provided by a company that is already highly certified for cell transplantation.

    It is hard to tell. If everything is in order, an approval within a year after the clinical trial could happen.

    Wise.
    thanks for filling me in so what you are saying is trails hop fill will take 2 years buy 2011 it will go to FDA hop fill 1 year later we should see some thing as i say i do hope trails will not take years ? as you say FDA will have the final say would this be right

  3. #23
    I probably missed this in the explanation so I'm going to ask anyway. Can we still sign up for these trials or have they already been filled with participants?

  4. #24
    Senior Member Leo's Avatar
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    Quote Originally Posted by Vike View Post
    I probably missed this in the explanation so I'm going to ask anyway. Can we still sign up for these trials or have they already been filled with participants?
    They haven't started yet it will be posted here I would think when they are ready.

    However there is some criteria you may want to start preparing for, example tilt table or bear weight for an hour a day I think.

    www.nascinet.org

    oh yeah and raise funds www.justadollar.org
    http://justadollarplease.org/

    2010 SCINet Clinical Trial Support Squad Member

    "You kids and your cures, why back when I was injured they gave us a wheelchair and that's the way it was and we liked it!" Grumpy Old Man

    .."i used to be able to goof around so much because i knew Superman had my back. now all i've got is his example -- and that's gonna have to be enough."

  5. #25
    Senior Member Leo's Avatar
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    Quote Originally Posted by Donnie View Post
    I was told by 5 different doctors that my cord was transected because of the large piece of vertabral body that travelled through the canal. This was what they saw through CT scan. It is my understanding that those show bone and therefore there could still be cord intact. I went through the op report and it never said the cord was transected just that the vertabral body retropulsed through the canal which was taken out during surgery. Is there a MRI machine that is high tech enough to see the cord and if so does Mayo Clinic have one?
    I sure think so Donnie,

    I had one done at our local hospital and the radiologist was able to point it out to me and show me where it was atrophied. pretty amazing

    googlr

    http://images.google.com/images?q=sp...N&hl=en&tab=wi
    http://justadollarplease.org/

    2010 SCINet Clinical Trial Support Squad Member

    "You kids and your cures, why back when I was injured they gave us a wheelchair and that's the way it was and we liked it!" Grumpy Old Man

    .."i used to be able to goof around so much because i knew Superman had my back. now all i've got is his example -- and that's gonna have to be enough."

  6. #26
    Quote Originally Posted by Vike View Post
    I probably missed this in the explanation so I'm going to ask anyway. Can we still sign up for these trials or have they already been filled with participants?
    None of the centers are recruiting yet and so you don't have to worry. At the present, we are holding investigator meetings to nail down the protocol. Once that is complete, we go to the FDA to apply for an IND (which is their permission to go ahead wit the trial) and apply to the IRB (which is the institutional review board of the hospital).

    In the last meeting, we have decided that we will probably do a phase II trial in the U.S. first, this fall. This will postpone the phase III trial until early 2010. In that phase III trial, we will have a 6-month period during which the subjects are examined three times and strongly encouraged to start standing for at least an hour a day. The standing can be done with a tilt table, a standing frame, a glider.

    So, in summary. I think we will be doing a phase II study in Brackenridge. That will start hopefully in November 2009. The Phase III study will start probably in January or February of 2010. The treatment phase of the Phase III will not start until early third Quarter in 2010. Please note that this is a very ambitious schedule and depends on ability to raise funds as well.

    Wise.

  7. #27
    Senior Member Schmeky's Avatar
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    Dr. Young,

    Assuming everything goes as scheduled, are you indicating Phase III will conclude sometime in 2010, then approval from the FDA will be applied for, thus allowing wide scale treatment in 2011/2012?

  8. #28
    Quote Originally Posted by Schmeky View Post
    Dr. Young,

    Assuming everything goes as scheduled, are you indicating Phase III will conclude sometime in 2010, then approval from the FDA will be applied for, thus allowing wide scale treatment in 2011/2012?
    Schmeky,

    No. The phase III will take at least a year. So, it will not conclude until 2011. We are hoping that the trial in China will start in 2010 as well. If both trials are positive, the FDA may approve the therapy by 2012. This all assumes that we start according to schedule.

    This is our goal. I don't know if we will achieve it but we will try. I believe in setting ambitious goals and working hard to get there.

    Wise.

  9. #29

    Smile

    Quote Originally Posted by Wise Young View Post
    None of the centers are recruiting yet and so you don't have to worry. At the present, we are holding investigator meetings to nail down the protocol. Once that is complete, we go to the FDA to apply for an IND (which is their permission to go ahead wit the trial) and apply to the IRB (which is the institutional review board of the hospital).

    In the last meeting, we have decided that we will probably do a phase II trial in the U.S. first, this fall. This will postpone the phase III trial until early 2010. In that phase III trial, we will have a 6-month period during which the subjects are examined three times and strongly encouraged to start standing for at least an hour a day. The standing can be done with a tilt table, a standing frame, a glider.

    So, in summary. I think we will be doing a phase II study in Brackenridge. That will start hopefully in November 2009. The Phase III study will start probably in January or February of 2010. The treatment phase of the Phase III will not start until early third Quarter in 2010. Please note that this is a very ambitious schedule and depends on ability to raise funds as well.

    Wise.
    This is great news
    you say it is very ambitious schedule and depends on getting funds I think if trials is showing good i am sure the money will come in i hope that we do not miss these dates

  10. #30
    The third is finding that over 90% of people who have "incomplete" spinal cord injury are able to recover independent walking. This is really quite a finding and one that one would not expect unless one only needs few axons to achieve walking.

    Wise.[/QUOTE]

    Dr.Wise this is a very impressive finding, do you think that patients who undergoes this procedure with Umbilical Cord Blood & Lithium should reply the procedure in future again or its needet just once till another therapy for chronics comes out? Because I read that people are going in Beike for 1,2,3 sessions?!
    I am an incomplete SCI 10 years post , do you think we all belong in that group even that we dobt have a leg movements for the moment?

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